MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM ; ALARM, CONDITIONED RESPONSE ENURESIS

Model Number M05

Device Problems Device Alarm System (1012); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 04/01/2019

Event Type  Injury  

Event Description

Bedwetting alarm is erratic and not operating correctly.The alarm is getting very hot when i am inserting the sensor.It is not normal and cannot be used as directed and expected.My son can't use it at night this way.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8487305
• MDR Text Key: 141172369
• Report Number: MW5085611
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR